A cleft (lip and) palate is the most common congenital abnormality of the face and skull with a significant social impact, affecting speech, hearing, feeding, oral behavior, dentition and satisfaction with appearance. These consequences have a long-term and negative impact on social integration and well-being. The World Health Organization (WHO) highlights the significant financial costs, including morbidity, health care costs, emotional distress and social exclusion for patients, their families and society. The purpose of this study is to compare high- and low-intensity speech intervention in children with a cleft (lip and) palate based on the perceptions of the providers of the intervention (primary care speech-language pathologists) and the recipients of the intervention (children with a cleft (lip and) palate and their parents). Individual semi-structured interviews will be conducted with both intervention providers and recipients to explore perceptions and experiences, as well as acceptability of the two speech intervention intensities. Potential participants will be told that the interview will be recorded. The actual interviews will take place at a location and time that is most convenient for the participants. Each interview will be recorded using a Roland R-05 high-quality audio recorder. After conducting the interviews, all participants will be asked to complete a questionnaire regarding their demographics. In addition, data regarding the type of cleft, time and manner of closure of the cleft, any secondary surgery and otological/audiological data will be collected from the medical records of the children with a cleft (lip and) palate. Based on this qualitative study, possible adjustments to the high-intensity therapy protocol can be made. In doing so, these modifications will be relevant to these key stakeholders. This will also facilitate the implementation and widespread use of high-intensity speech therapy in clinical speech therapy practice.
Belgian Dutch-speaking children with a cleft palate with or without a cleft lip
Aged between 4 and 12 years,
Presence of at least one compensatory speech error in their speech based on the perceptual assessment of one experienced speech-language pathologist
Children with syndromic clefts
Oronasal fistula
Velopharyngeal insufficiency
Hearing disabilities based on pure tone audiometry (>25 dB HL)
The study population consists of children with cleft palate who participated in the associated randomized clinical trial evaluating high- and low-intensity speech therapy, their parents/caregivers, and the speech-language pathologists who provided the intervention. Participants will be selected from children and families enrolled in the clinical trial and from the speech-language pathologists providing the trial interventions.
Cohort
Retrospective
High-intensity speech therapy for children with cleft palate
BehavioralHigh-intensity speech therapy consisted of five 30-minute speech therapy sessions per week over two separate 2-week periods, with a 6-week rest period between the two periods. The intervention comprised a total of 10 hours of speech therapy.
Low-intensity speech therapy for children with cleft palate
BehavioralLow-intensity speech therapy consisted of two 30-minute speech therapy sessions per week over a 10-week period. The intervention comprised a total of 10 hours of speech therapy.
Perceived acceptability of high- and low-intensity speech intervention
Perceptions and experiences of children with cleft palate, their parents/caregivers, and speech-language pathologists regarding the acceptability of high-intensity and low-intensity speech therapy. Acceptability will be explored through semi-structured interviews and examined across the seven constructs of the Theoretical Framework of Acceptability: affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy. Qualitative thematic analysis will be used to identify perceptions, experiences, and factors influencing acceptability of the two treatment intensities.
Perceived feasibility and burden of high- and low-intensity speech therapy
Perceptions of children with cleft palate, their parents/caregivers, and speech-language pathologists regarding the practical feasibility and burden associated with high- and low-intensity speech therapy. This includes experiences related to treatment frequency and duration, travel, scheduling, school and family commitments, fatigue, and other competing demands. Data will be collected through semi-structured interviews and analysed qualitatively.
Perceived therapeutic value of high- and low-intensity speech therapy
Perceptions of children with cleft palate, their parents/caregivers, and speech-language pathologists regarding the therapeutic value and perceived effectiveness of high- and low-intensity speech therapy. This includes perceptions of speech progress, continuity, repetition, intensity, and the extent to which the intervention supports speech development. Data will be collected through semi-structured interviews and analysed qualitatively.
Emotional and motivational experiences of high- and low-intensity speech therapy
Emotional and motivational experiences of children with cleft palate, their parents/caregivers, and speech-language pathologists during high- and low-intensity speech therapy. This includes experiences of enjoyment, motivation, fatigue, frustration, and other emotional responses to the intervention. Data will be collected through semi-structured interviews and analysed qualitatively.
Treatment preferences and contextual factors influencing acceptability of speech therapy intensity
Preferences of children with cleft palate, their parents/caregivers, and speech-language pathologists regarding high- and low-intensity speech therapy, and contextual factors influencing these preferences. Factors related to the child, family, therapist, treatment setting, scheduling, and everyday circumstances will be explored. Data will be collected through semi-structured interviews and analysed qualitatively to identify factors that facilitate or hinder acceptance of different treatment intensities.
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University Ghent
Lead sponsor
Research Foundation Flanders
Collaborator
